1. Gaiva Leoniene
217 Tulip Cir, Island Lake, IL 60042
224-622-2892
gaivaleo@gmail.com
OBJECTIVE
Obtain a position allowing the utilization and expansion of my skills in clinical research.
EDUCATION
 Master’s of Science Degree, Kaunas University of Technology
QUALIFICATIONS SUMMARY
 Working knowledge of Federal Regulations, HIPPA,GCP and ICH guidelines
 Solid understanding of medical terminology
 Proficientwith MicrosoftExcel,Outlook,Word, PowerPoint, Share Pointand various
databases
 Ability to problem solve,follow through and lead by example in order to achieve
company goals
 Strong organizational, multitasking and time management abilities and detail oriented
 Capable of learning and excelling in a difficult,unfamiliar environment
WORK EXPERIENCE
Clinical DocumentationSpecialist/Clinical Studies Specialist– QAand Compliance: Randstad
Pharma on Assignment toAbbvie
April 2014 to Present
 Supporting Auditors and ProjectManager with FDA Submission Readiness for six (6) global
studies.
 Performing Reconciliation of 1572s, FDFs & QA Audit Reports.
 Assisting auditors with TMF review, organizing and filing documents according to sponsor’s
filing structure, SOPsand Federal Regulation guidelines.
 Responsible forQC Review and Itemization of all essential documents per each TMF.
 Identifying potential gaps in preparedness for Regulatory inspection.
 Managing, reorganizing and tracking of TMF to ensure files are foraudit ready.
 Generating and Maintaining study Trackers.
 Support auditor’s team withdocumentation task as requested.
 Managing deadlines in accordancewith projectplans by prioritizing tasks.
 Ensuring compliance withGCP, SOP requirements, and industry standards.
Clinical RecordsTechnician:Randstad Pharma on Assignment to Takeda Pharmaceuticals
April 2013- March 2014
 Member of the clinicalteam responsible forconducting Phase I- IV studies according to
Federal Regulations and ICH guidelines.
 Supported clinical team by primarily tracking, organizing and filing Phase I- IV study
documents accordingto Federal Regulations and ICH guidelines.

2.  Received, reviewed and organized essential documents from the Clinical Operations,
CRAs and CROs. Ensured documents are appropriate and content of those documents is
accurate, consistent/compliant withcompany’s SPOs,regulatory requirements and
corporate policies and procedures.
 Reviewed documents according to Guidelines forFDA submissions.
 Managed and maintained TMF.Correctly indexed and cataloged all types of clinical
documents records forassigned unit, using an electronic records management system
(RMS)·
 Correctly placed physical files in designated location within central file, or as required,
and updates the information in the RMS pertaining to the physical location of the files
(using a bar-code scanning device and standard data upload procedure, or using a
manual procedure)·
 Verified the accuracy of the indexing, cataloguing, and file-locating information entered
(by self) into RMS, using standard features of the RMS together with business tools such
as MS Excel and standard procedures including auditing of the files/boxes against the
information in RMS
 Meted or exceeded work quality and productivity standards·
 Maintained confidentiality and security of clinicaldocuments; maintains confidentiality
of records-related activities.
DocumentationSpecialistandClinical DataManagement:Symphony Clinical Research
(Formally known as Clinical Resource Network) Vernon Hills IL, February 2011-August 2012
 Performed management of Trial Master File, ensuring TMFs were compliant with GSP,
ICH guidelines and Federal Regulations.
 CRF data review, preparation forentry, query processing discrepancy management.
 Developed study specific database requirements and edits checkrequirements with the
help of Clinical Research Associates (CRAs) and field monitors.
 Activated and tracked new sites, users across studies for EDCstudies.
 Assisted in CRF design/development.
 Assisted in database design and validation activities (forpaper based trials).
 Assisted in development of data verificationaudit listings and other audit activities.
 Assisted the clinical team responsible forconducting Phase I-IVstudies according to
Federal Regulations and ICH guidelines.
 Performed data management activities on both paper based and electronic data capture
(EDC)studies.
 Created and maintained data management trackers and checklists formultiple projects.
 Responsible fordata entry and management activities across multiple trials in
accordancewith FDA regulations and GCP guidelines for Phase I-IV trials.
 Ensured adequate filing and archiving of relevant data and documentation.
 Worked effectively asa team player with other departments.
Clinical ResearchAdministrative Assistant:ClinicalResource Network,Vernon Hills IL,
September 2010-February 2011
 Providedsupport to Study Management team withdata query resolution, tracking study
documentation and study supplies, and maintained study documentation files.
 Maintained trial master files.
 Managed allocation of study supplies as required.
 Developed and maintained centralized database to trackand organize vendor
documentation.
 Oversaw and participated in internal and sponsor requested audits to ensure
compliance with all Standard Operating Procedures.
 Maintained a database of clinicaltrial shipments, and ensured that there were adequate
supplies of clinical trial materials to meet project needs.
 Planned, ordered and distributed non-drug clinical trial supplies.

3.  Responsible forlogging in receivedCRFs and transferring data fromthe CRFs into the
database.
 Scanned and filed study documents, Note to Files, Data Clarification Forms and vendor
documents.
 Providedadministrative support including, but not limited to, typing documents,
creating tracking spreadsheets and faxing.
 Assisted the CRA during the preparation forthe investigator study initiation meeting.
AdministrativeAssistant: Unique Realty and Investments Management Inc., Lincolnshire, IL,
February 2006- September 2010
 Responsible forscheduling meetings forinvestors and all employees; composed and
distributed inter-departmental memorandums (emails, documentary and voice)
ensuring timely delivery and receipt of important information while at the time
maintaining confidentiality.
 Prepared and assembled media kits for marketing and public relations departments,
created documents related to sales and investments presentations.
 Established and managed all electronic and paper records.
 Responsible forreal estate services-related compliance with all local, state, and federal
regulations and related agreements.
 Created, reviewed and revised addendums and amendments to contracts.
 Ability to read legal descriptions.